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Cleaning Validation: A Practical Approach

Autor Gil Bismuth, Shosh Neumann
en Limba Engleză Hardback – 31 ian 2000
Offering a detailed, step-by-step guide to building a compliant cleaning validation program, Cleaning Validation: A Practical Approach covers trends in control, procedures, cleaning agents and tools, sampling techniques, analytical methods, and regulatory issues. The author provides practical examples, database formats, standard operating procedures, work instructions, protocols, and reports. He gives readers the tools they need to develop an effective and manageable program that will not only be acceptable to both US and non-US regulatory authorities but will conserve an organization's time, money, and people resources.
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Specificații

ISBN-13: 9781574911084
ISBN-10: 1574911082
Pagini: 200
Dimensiuni: 178 x 254 x 17 mm
Greutate: 0.53 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press

Public țintă

Microbiologists, analytical chemists, and medicinal chemists

Cuprins

DEVELOPING A CLEANING PROCEDURE . Contamination Control. Regulatory Requirements. Cleaning Basic Concepts. Cleaning Procedure. DEVELOPING A CLEANING VALIDATION PROGRAM. Cleaning Validation Policy. Contamination Acceptance Limits. Cleaning Validation Planning & Execution. Cleaning Validation Monitoring & Maintenance. Special Cleaning Validation Issues. Cleaning Validation Trends. Appendices: Cleaning & Cleaning Validation Procedures. Cleaning. Cleaning Validation.

Descriere

Offering a detailed, step-by-step guide to building a compliant cleaning validation program, Cleaning Validation: A Practical Approach covers trends in control, procedures, cleaning agents and tools, sampling techniques, analytical methods, and regulatory issues. The author provides practical examples, database formats, standard operating procedures, work instructions, protocols, and reports. He gives readers the tools they need to develop an effective and manageable program that will not only be acceptable to both US and non-US regulatory authorities but will conserve an organization's time, money, and people resources.